17 November | 2021
Prilenia Receives Fast Track Designation for Pridopidine for the Treatment of Huntington’s Disease
Fast Track designation may accelerate the registration process for pridopidine by providing the ability to file a rolling NDA and qualify for priority review
Naarden, NL, 17 November 2021 – Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pridopidine for development as a potential treatment for Huntington’s Disease (HD).
Fast Track is a process designed to facilitate the development and expedite the review of new treatments for serious conditions with unmet medical need such as HD. Drugs that receive Fast Track designation may be eligible for more frequent communications with the FDA to review the drug's development plan, including the extent of data needed for approval. Drugs with Fast Track designation may also qualify for accelerated approval and priority review of new drug applications.
Pridopidine is currently being assessed in PROOF-HD (PRidopidine Outcome On Function in Huntington Disease), a global phase 3 clinical trial that very recently completed patient enrollment. Pridopidine acts as a highly selective and potent Sigma-1 Receptor (S1R) agonist.
“Receipt of Fast Track designation from the FDA underscores the urgency to address a significant unmet need for patients with Huntington’s Disease,” said Dr. Michael R. Hayden, CEO and Founder of Prilenia.
“HD is one of the most devastating neurodegenerative disorders, impacting not only patients but their families. At the present time, there is no approved treatment to delay onset or slow disease progression.
We look forward to working closely with the FDA in making pridopidine a potential option for these patients.”
“The FDA Fast Track designation is an important milestone, as it provides opportunities to work collaboratively with the FDA to accelerate pridopidine’s development for the treatment of Huntington’s Disease,” said Henk Schuring, Chief Regulatory and Commercialization Officer at Prilenia.
This designation follows Prilenia’s recent company announcements, including the PROOF-HD completion of enrollment ahead of schedule and the closing of series B financing round.